Health Canada Introduces Trial Rules in Wake of Tuberculosis Scare
October 24, 2006
Health Canada introduced new clinical drug trial rules intended to screen out TB-infected participants after a study last year in Montreal included a man with the disease, thus exposing dozens. The binding rules require Phase I trials to screen all potential participants for TB symptoms and to ask if they use IV drugs or have HIV. Trial candidates would be asked if they ever had TB, and whether they ever experienced unexplained chest pains, weight loss, fever, loss of appetite, night sweats or had coughed up blood. If a candidate answers yes to any of the questions and has not been tested or examined to exclude the possibility of being TB-infected, his or her participation in the trial is prohibited by federal law. The rules are a response to reports of a clinical drug trial held last year by SFBC Anapharm, in which a subject with active, visible signs of TB was allegedly housed on-site with trial participants and staff members. Earlier this year, 20 people in that trial tested positive for exposure to the disease.
10.15.2006; Dene Moore
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This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.